Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the implications for his policies of international no-fault compensation schemes for medicine-induced harm, including those in New Zealand, Sweden and Denmark, in relation to sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department’s consideration of the Hughes Report’s recommendations for redress for those harmed by sodium valproate will take account of how other countries have chosen to approach this issue.
This is a complex, cross-Government policy area involving multiple organisations. This work requires coordinated input from several departments, and we will provide a further update in due course.
I met with the Patient Safety Commissioner in December 2025, to discuss progress following the Hughes Report, and made clear the Department’s expectation of continued, proactive engagement with the Patient Safety Commissioner and key stakeholders.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment has been made of the MHRA’s effectiveness at communicating known risks of sodium valproate, particularly in pregnancy, prior to 2018.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
As with all medicines, the safety of valproate has been kept under continual review by the Medicines and Healthcare products Regulatory Agency (MHRA), ensuring the product information reflects what is known about valproate.
The known risks of valproate are outlined in the Summary of Product Characteristics and Patient Information Leaflet. Over the years information about the reproductive risks has been updated as data emerged. The MHRA also issued communications via their bulletins Current Problems and Drug Safety Update on valproate, particularly the reproductive risks.
The report of the Independent Medicines and Medical Devices Safety Review published in 2020 examined how the healthcare system, including MHRA and its predecessors, responded to risks from medicines and medical devices, including valproate, and annex C of the report includes a timeline of key events including communications and updates to the product information undertaken by the MHRA.
Since 2016, the MHRA has carefully reviewed feedback from patients and healthcare professionals within the Valproate Stakeholder Network (VSN) to assess the effectiveness of communications on the risks of sodium valproate use during pregnancy. The VSN also informed the design of a pictogram warning on the medicine carton and blister pack.
In addition, the MHRA has rigorously monitored the effectiveness of the communication of the known risks through healthcare professional and patient surveys started in 2014, which have formed part of a European Union wide post authorisation safety study for valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether interim compensation payments have been considered for families involved in the first ten claims of the FAC litigation concerning sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department has not specifically considered interim compensation for the families involved in the Fetal Anti‑Convulsant litigation. On redress more broadly, I met with the Patient Safety Commissioner in December 2025, to discuss progress on the Hughes Report and made clear that the Department’s expectation of continued, proactive engagement with the Patient Safety Commissioner and key stakeholders.
This is a complex, cross‑Government policy area involving multiple organisations. As set out in the Hughes Report, the Government is carefully considering the Patient Safety Commissioner’s recommendations, including the proposed approaches to redress for those harmed by sodium valproate. This work requires coordinated input from several departments, and we will provide a further update in due course.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what discussions he has had with his international counterparts on the relevance of the UN Convention on the Rights of Persons with Disabilities to individuals harmed by sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
My Rt Hon. Friend, the Secretary of State for Health and Social Care, has not had specific discussions with international counterparts regarding the relevance of the UN Convention on the Rights of Persons with Disabilities to individuals harmed by sodium valproate. Our focus remains on improving the safety of sodium valproate, so it is not used for women or girls of childbearing potential unless a pregnancy prevention plan is in place and other treatments are ineffective or not tolerated. The Government is also carefully considering the recommendations made by the Patient Safety Commissioner in The Hughes Report, which sets out options for redress for those harmed by valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential merits of providing financial compensation to people harmed by sodium valproate by using the same compensation process as for thalidomide survivors.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department’s consideration of the Hughes Report’s recommendations for redress for those harmed by sodium valproate will include comparison with the compensation process for thalidomide survivors. However, this is a complex, cross-Government policy area involving multiple organisations. This work requires coordinated input from several departments, and we will provide a further update in due course.
I met with the Patient Safety Commissioner in December 2025, to discuss progress following the Hughes Report and made clear that the Department’s expectation of continued, proactive engagement with the Patient Safety Commissioner and key stakeholders.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what data NHS England holds on emergency admissions, emergency care and levels of unmet need among individuals harmed by sodium valproate.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
The requested data is not centrally held. NHS England does not hold data on admissions or attendances that specifically identifies individuals harmed by sodium valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the forthcoming testing regime for vaping products will require imported liquids to undergo the same emissions and ingredient analysis as UK-made liquids before being placed on the UK market.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
Powers in the Tobacco and Vapes Bill allow us to establish a new product registration scheme for tobacco, vaping, and nicotine products, including testing requirements.
On 8 October 2025, we published a call for evidence on a number of topics related to tobacco, vaping, and nicotine products, including the proposal to introduce a new product registration scheme. The evidence gathered will inform development of policy and a subsequent consultation next year.
Any new testing requirements introduced following consultation will apply to products produced in the United Kingdom and those imported into the UK.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he will publish a timetable for introducing product-verification checks under the new vape registration scheme, in order to assist Trading Standards in identifying non-compliant high-capacity devices at point of sale.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
Powers in the Tobacco and Vapes Bill allow us to establish a new product registration scheme for tobacco, vaping, and nicotine products. On 8 October 2025, we published a call for evidence on a number of topics related to tobacco, vaping, and nicotine products. This includes the proposal to introduce a new product registration scheme.
In the call for evidence, we are seeking information on how best to implement the registration scheme. The evidence gathered will inform development of policy and a subsequent consultation next year.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the level of resources required by the MHRA to implement the new registration and testing regime for vaping products established under the Tobacco and Vapes Bill.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
No assessment has yet been made as the registration scheme is still in the early stages of policy development. On 8 October 2025, we published a call for evidence on a number of topics related to tobacco, vaping and nicotine products, including the proposal to introduce a new product registration scheme.
However, given the nature of vaping products, which are not healthcare products, officials from the Department and the Office for Product Safety and Standards (OPSS) are considering whether OPSS would be better placed to oversee the future register. The Department and the Medicines and Healthcare products Regulatory Agency will continue to be responsible for the current notification systems until further notice.
Powers in the bill will allow us to charge a fee for the ongoing and continuous registration of products. Exact details on fees, as well as the future registration scheme, will be subject to future consultation.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what guidance he plans to issue to local Trading Standards teams on identifying high-capacity non-compliant disposable vapes under the powers created by the Tobacco and Vapes Bill.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
It has been illegal for businesses to sell or supply single-use vapes since 1 June 2025. The Government is investing £10 million of new funding in Trading Standards in 2025/26, to support the enforcement of illicit and underage tobacco and vape sales. As part of this package, we have provided training to over 760 Trading Standards officers on the single-use vapes ban, ensuring they have a strong understanding of the regulations and are confident in enforcing them.
Through this programme, we are also funding the Vaping Expert Panel, which provides guidance to Trading Standards officers on vaping products to support the consistent enforcement of regulations. The panel has published 20 pieces of guidance, and Trading Standards officers are able to contact the panel if they would like further clarification or advice.